Chronic Heart FailureCHF-COVReducedNCT05089162
CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and Blood sample retrieved for biological assessment and biobanking in people with Chronic Heart Failure and Reduced Ventricular Ejection Fraction, run by Pr. Nicolas GIRERD at 1 site in France.
Trial summary
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Reduced Ventricular Ejection Fraction
- What is being tested?
- Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and Blood sample retrieved for biological assessment and biobanking
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2021to 14 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
- Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
- Age ≥18 years
- Patients having received complete information regarding the study design and having signed their informed consent form.
- Patient affiliated to or beneficiary of a social security scheme.
Who cannot join
- Comorbidity for which the life expectancy is ≤ 3 months
- Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- Pregnant woman, parturient or nursing mother
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
Show all 9Show fewer
- Adult person who is unable to give consent
- Person deprived of liberty by a judicial or administrative decision,
- Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
Nicolas GIRERD, MD, PhD, +33383157322 ext. +333, n.girerd@chru-nancy.fr
About this study
Official title: Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.
The main objective of the CHF-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.
- Being tested
- Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds, Blood sample retrieved for biological assessment and biobanking, Telephone follow-up, Kansas City Cardiomyopathy Questionnaire (KCCQ)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination centered on congestionProcedure or surgery
Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasoundsProcedure or surgery
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional
Blood sample retrieved for biological assessment and biobankingProcedure or surgery
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
Telephone follow-upOther
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
Kansas City Cardiomyopathy Questionnaire (KCCQ)Behavioural
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day | Experimental | Not described Receives: Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds; Procedure: Blood sample retrieved for biological assessment and biobanking; Other: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of death from all causes
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)
Measured: 24 months after day hospitalization or consultation
Rate of hospitalisation for acute heart failure
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)
Measured: 24 months after day hospitalization or consultation
Rate of day-hospital or in-home IV diuretics injection for acute HF
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)
Measured: 24 months after day hospitalization or consultation
Secondary outcomes (21)
Rate of death from all causes
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)
Measured: 24 months after day hospitalization or consultation
Rate of hospitalisation for acute heart failure
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4)
Measured: 24 months after day hospitalization or consultation
Rate of death from all causes
Measured: 24 months after day hospitalization or consultation
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 8)
Measured: 24 months after day hospitalization or consultation
Rate of day-hospital or in-home IV diuretics injection for acute HF
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 7)
Measured: 24 months after day hospitalization or consultation
Rate of hospitalisation for cardiovascular reason
Measured: 24 months after day hospitalization or consultation
Rate of death from all causes
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 11)
Measured: 3, 12 and 24 months after day hospitalization or consulation
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 10)
Measured: 24 months after day hospitalization or consultation
Rate of cardiovascular death
Measured: 24 months after day hospitalization or consultation
NYHA (New York Heart Association) class measured
Measured: 3, 12 and 24 months after day hospitalization or consultation
Natriuretic peptides
BNP or Nt-Pro BNP
Measured: At inclusion
Renal function
Assessed by glomerular filtration rate
Measured: At inclusion
Plasma volume
calculated from haemoglobin and haematocrit value
Measured: At inclusion
Rate of Bilirubin
Measured: At inclusion
Rate of ASAT
Measured: At inclusion
Rate of ALAT
Measured: At inclusion
Rate of V factor
Measured: At inclusion
Blood potassium concentration
Measured: At inclusion
Circulating NtProBNP
Measured: At inclusion
Liver elastography value
Measured with Fibroscan®
Measured: At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: At inclusion and 3, 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start14 Dec 2021
- Primary completion14 Dec 2028 (estimated)
- Study completion14 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089162
- Sponsor's protocol ID
- 2020PI145-2
- Acronym
- CHF-COVReduced
- Status last verified
- Mar 2023
- First submitted
- 11 Oct 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
- ClinicalTrials.gov ID
- NCT05089162
- Acronym / sponsor ID
- CHF-COVReduced / 2020PI145-2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 14 Dec 2028 (estimated)
- Study completion
- 14 Jun 2029 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.
The main objective of the CHF-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day | Experimental | Procedure: Clinical examination centered on congestion, Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds, Procedure: Blood sample retrieved for biological assessment and biobanking, Other: Telephone follow-up, Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
- Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
- Age ≥18 years
- Patients having received complete information regarding the study design and having signed their informed consent form.
- Patient affiliated to or beneficiary of a social security scheme.
Key exclusion criteria (9 listed)
- Comorbidity for which the life expectancy is ≤ 3 months
- Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- Pregnant woman, parturient or nursing mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination centered on congestionClinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation | Procedure or surgery | Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day |
| Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasoundsCardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional | Procedure or surgery | Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day |
| Blood sample retrieved for biological assessment and biobankingBlood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation | Procedure or surgery | Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day |
| Telephone follow-upTelephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation | Other | Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day |
| Kansas City Cardiomyopathy Questionnaire (KCCQ)Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge | Behavioural | Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day |
Primary outcome
Rate of death from all causes
Time frame: 24 months after day hospitalization or consultation
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 2 and 3)
Rate of hospitalisation for acute heart failure
Time frame: 24 months after day hospitalization or consultation
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time frame: 24 months after day hospitalization or consultation
composite endpoint : rate of death from all causes, hospitalisation for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 1 and 2)
21 secondary outcomes
Rate of death from all causes
Time frame: 24 months after day hospitalization or consultation
Rate of hospitalisation for acute heart failure
Time frame: 24 months after day hospitalization or consultation
Rate of death from all causes
Time frame: 24 months after day hospitalization or consultation
Rate of hospitalisation for acute heart failure
Time frame: 24 months after day hospitalization or consultation
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time frame: 24 months after day hospitalization or consultation
Rate of hospitalisation for cardiovascular reason
Time frame: 24 months after day hospitalization or consultation
Rate of death from all causes
Time frame: 3, 12 and 24 months after day hospitalization or consulation
Rate of hospitalisation for acute heart failure
Time frame: 24 months after day hospitalization or consultation
Rate of cardiovascular death
Time frame: 24 months after day hospitalization or consultation
NYHA (New York Heart Association) class measured
Time frame: 3, 12 and 24 months after day hospitalization or consultation
Natriuretic peptides
Time frame: At inclusion
Renal function
Time frame: At inclusion
Plasma volume
Time frame: At inclusion
Rate of Bilirubin
Time frame: At inclusion
Rate of ASAT
Time frame: At inclusion
Rate of ALAT
Time frame: At inclusion
Rate of V factor
Time frame: At inclusion
Blood potassium concentration
Time frame: At inclusion
Circulating NtProBNP
Time frame: At inclusion
Liver elastography value
Time frame: At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: At inclusion and 3, 6 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and Blood sample retrieved for biological assessment and biobanking in people with Chronic Heart Failure and Reduced Ventricular Ejection Fraction, run by Pr. Nicolas GIRERD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GIRERD, MD, PhD (0033383157322 ext. +33, n.girerd@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of death from all causes (time frame: 24 months after day hospitalization or consultation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.